Theranos, the controversial blood-testing startup, has been accused by federal regulators of failing to meet quality control standards in its Newark, California, lab. But has it actually harmed patients?
A report from the Wall Street Journal claims that Theranos performed an important hematology blood test on 81 patients during a six-month span in 2015, despite getting erratic results. The reporters claim to have seen a federal inspection report detailing this and other transgressions, which may have put patient safety at risk.
From the WSJ report:
The test that inspectors found Theranos kept doing despite the erratic quality-control results was a hematology test that measures how long it takes blood to clot, the people familiar with the matter said. The test is an important part of the treatment regimen for patients who are at risk of strokes or have blood disorders. Inaccurate results from the test can be especially serious for patients taking blood thinners such as warfarin, also known by its brand name Coumadin. Too much warfarin can cause fatal bleeding, while too little can leave patients vulnerable to clots and strokes, according to medical experts.
The new report follows a January 2016 summary letter from the federal Centers for Medicare and Medicaid Services, or CMS, which found “serious deficiencies” in five categories, including hematology. In response to these concerns, Theranos brought on additional personnel at its Newark lab, including board-certified pathologist Kingshuk Das.
Company spokesperson Brooke Buchanan said the tests in question were “run on conventional equipment using venipuncture samples,” and that no more than 40 patients were impacted.
In a statement, Theranos’s Das stressed that the company has “no reason to believe that these issues have affected patients’ health.” He also said that the lab has made improvements in the wake of federal inspections.
Theranos made a name for itself with a bold claim that its novel technology, a machine called Edison, could perform hundreds of different tests, including a test for HIV and measles, with just a few droplets of blood. The company, which was founded by Stanford dropout Elizabeth Holmes, has been in regulatory hot water since October of 2015. In that month, the U.S. Food and Administration declared its specimen-collection kit to be an “uncleared medical device.” Theranos is still awaiting FDA approval for its tests (its herpes test has been cleared); until then, it is relying on traditional blood-testing machines. The company performs 90% of its tests in its lab in Arizona, rather than in Newark.